Effect of Preoperative Oral Magnesium on Emergence Agitation

NCT07082894 | Recruiting

• 1 other identifier: 36264PR1217/5/25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled study will be conducted to evaluate the effects of preoperative oral magnesium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.

Conditions

Magnesium; Emergence Agitation; Adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence agitation

  Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour

  Up to 1 hour after surgery.

Secondary Outcomes (6)

• Parental separation anxiety

  Perioperative

• Mask Acceptance Score

  Perioperative

• Postoperative pain

  Up to 1 hour after surgery.

• Total dose of rescue fentanyl

  Up to 1 hour after surgery.

• Pediatric Anesthesia Emergence Delirium scale scores

  Up to 1 hour after surgery.

Study Arms (2)

Magnesium group

EXPERIMENTAL

cases will receive preoperative oral magnesium dose of 120 mg at one hour before surgery

Drug: Magnesium

Control group

PLACEBO COMPARATOR

cases will receive oral lemon juice at one hour before surgery.

Other: Placebo control

Interventions

Magnesium DRUG

preoperative oral magnesium dose of 120 mg at one hour before surgery will be given.

Magnesium group

Placebo control OTHER

preoperative oral lemon juice at one hour before surgery will be given.

Control group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Both gender
• to 7 years age
• American Society of Anesthesiologists (ASA) Physical Status I or II
• Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia

You may not qualify if:

• Parents declined to participate in the trial
• Children with behavioral changes; neurological or psychiatric diseases
• Physical or developmental delay
• Sedative or anticonvulsant medication
• Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders
• Allergy to magnesium

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Central Study Contacts

Radwa E Eissa, MD

CONTACT

01007473944; radwa.emad@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine

Model Details: Parallel assignment

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 24, 2025
• Study Start: July 25, 2025
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)